Vaping THC From Electronic Cigarettes (NCT02955329) | Clinical Trial Compass
CompletedPhase 3
Vaping THC From Electronic Cigarettes
United States8 participantsStarted 2019-03-20
Plain-language summary
This study aims to understand THC pharmacology and the safety of cannabis vaping, including the pharmacology and safety of co-administration of nicotine and THC. The study is designed as a within-subjects single-blinded crossover study. Fourteen smokers of tobacco cigarettes and cannabis will switch between three conditions, namely: (a) vaping cannabis leaf, (b) vaping tobacco containing nicotine and (c) vaping a combination of cannabis leaf and tobacco containing nicotine. All participants will vape each product with the PAX loose-leaf vaporizer. The study will be conducted during three outpatient visits separated by at least 48 hours. The order of treatment (cannabis leaf, tobacco with nicotine, cannabis leaf \& tobacco with nicotine) will be counterbalanced between subjects. Subjects will be blinded to the content of the vaporizer on the study day but will be told during screening that they will vape cannabis alone, tobacco alone, and cannabis plus tobacco with nicotine.
Who can participate
Age range
21 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion
* Age \>=21 years \<=70 years
* Regular user of tobacco cigarettes (daily or most days)
* Regular user of cannabis in any form (combusted or ingested) at least 5 days out of the month.
* Positive for Tetrahydrocannabinol (THC) on screening toxicology test
* Willing to abstain from tobacco smoking and all other combustible products (ex: cigars) for 12 hours prior to each outpatient hospital admission.
* Willing to abstain from smoking/ingesting cannabis for 12 hours prior to each outpatient hospital admission.
* Willing to abstain from using any kind of nicotine products for 12 hours prior to each outpatient hospital admission (ex: electronic cigarettes, nicotine replacement therapy).
* Saliva cotinine ≥ 30 ng/mL and/or NicAlert of 6
* Healthy (based on limited physical examination and medical history collected during screening)
* Heart rate \< 105 beats per minute (BPM)
* Systolic Blood Pressure \< 160 and \> 90 (considered out of range if both machine and manual readings are above/below these thresholds)
* Diastolic Blood Pressure \< 100 and \> 50 (considered out of range if both machine and manual readings are above/below these thresholds)
* Body Mass Index ≤\<=38.0
Exclusion
* Medical (The following unstable medical conditions):
* Heart disease
* Uncontrolled hypertension
* Thyroid disease (okay if controlled with medication)
* Diabetes
* Hepatitis B or C or Liver disease
* Glaucoma
* Prostatic hypertrophy
* History of paranoia after marijuana use
* Psychiatri…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean Delivered and Retained Doses
Timeframe: Study Day 1-3
2
Median Peak THC Concentration (Cmax)
Timeframe: Study Day 1-3
3
Median Peak Nicotine Concentration (Cmax)
Timeframe: Study Day 1-3
4
Median THC Exposure
Timeframe: Study Day 1-3
5
Median Nicotine Exposure
Timeframe: Study Day 1-3
6
Mean Heart Rate
Timeframe: Study Day 1-3
7
Mean Score on the Drug Effects Questionnaire (DEQ)
Timeframe: Study Day 1-3
8
Mean Scores on the Marijuana Craving Questionnaire-Short Form (MCQ-SF)